Multi-center, open-label, uncontrolled study to investigate the efficacy and safety of the transdermal contraceptive patch containing 0.55 mg ethinyl estradiol and 2.1 mg gestodene (material no. 80876395) in a 21-day regimen for 13 cycles in 1650 healthy female subjects - EU/LA/AUS Pearl Index study ? transdermal contraceptive patch

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 1650

Inclusion Criteria

1. Signed and dated informed consent 2. Healthy female subject requesting contraception 3. Age: 18 ? 35 years (inclusive); smokers must not be older than 30 years at the time of informed consent 4. Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous 6 months) 5. History of regular cyclic menstrual periods
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Pregnancy or lactation (less than 3 menstrual cycles before start of treatment) 2.Obesity (BMI>30.0 kg/m2) 3.Hypersensitivity to any ingredient of the study drug 4.Significant skin reaction to transdermal preparations or sensitivity to surgical/ medical tape 5.Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug (e.g., known skin disease with suspected alteration of dermal absorption or poor adherence of the patch such as psoriasis) 6.Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results 7.Any disease or condition that may worsen under hormonal treatment such as: CV -presence or a history of venous or arterial thrombotic/thromboembolic events (e.g., deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, incl.prodromi (e.g., transient ischaemic attack, angina pectoris) and conditions that could increase the risk to suffer from any of the above mentioned disorders, e.g., a family history indicating a hereditary predisposition - repeated measurements of SBP>140 mm Hg and/or DBP>90 mm Hg Liver - presence or history of liver tumors (benign or malignant) -presence or history of severe hepatic disease as long as liver function values have not returned to normal - jaundice and/or pruritus related to cholestasis (Gilbert?s syndrome excepted) - history of cholestatic jaundice associated with pregnancy or previous COC use Metabolic diseases - uncontrolled diabetes mellitus and/or diabetes mellitus with vascular involvement - severe dyslipoproteinemia Other diseases - malignant or premalignant disease - uncontrolled thyroid disorder - severe renal insufficiency or acute renal failure - history of hypertriglyceridemia-associated pancreatitis - pemphigoid gestationis during a previous pregnancy - history of herpes gestationis - otosclerosis-related hearing loss - history of migraine with focal neurologic symptoms - epilepsy - clinically significant depression - hereditary angioedema 8.Undiagnosed abnormal genital bleeding 9.Abuse of alcohol, drugs, or medicines (e.g., laxatives) 10.Other contraceptive methods: - sterilization - oral, vaginal, or transdermal hormonal contraception during treatment - intrauterine devices (IUDs) with or without hormone release - implants - long-acting preparations (e.g., Depot-MPA, monthly contraceptive injection) within a period of 3 times of the injection interval before start of treatment.11.Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results such as: - products containing St.John?s wort (Hypericum perforatum) - antibiotics (except for short-term treatment) - anticoagulants (e.g., heparin, coumarin) - antiepileptics (hydantoin derivatives [e.g., phenytoin] or carboxamide derivatives [e.g., carbamazepine, oxcarbamazepine], others [e.g., felbamate, topiramate]) - hypnotics and sedatives (e.g., barbiturate derivatives, primidone) - tuberculostatics (e.g., rifampicin) - oral antimycotics (e.g., griseofulvin, ketoconazole, itraconazole, fluoconazole) (except for single shot treatment) - virostatic agents (except for topical use [e.g., ritonavir]) - phenylbutazone - additional sex steroids and other drugs impairing ovaria

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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